News & Events
- June 14, 2017 - June 15, 2017
June 6, 2017 - June 7, 2017
Drug-Induced Liver Injury (DILI) Conference XVIIAsymmetry of Drug Safety and Efficacy in Clinical Trials with DILI- Toward Quantitative Estimate of Net Benefit to Patients June 6, 2017 – June 7, 2017 College Park Marriott Hotel and Conference Center Paul Watkins, Mark Avigan, John-Michael Sauer, Arie Regev, Gyongyi Szabo, John Senior Drug-induced liver injury (DILI) is a major problem for drug......
May 22, 2017
Second Annual Workshop On Clinical Outcome Assessments In Cancer Clinical TrialsAssessing Tolerability of Cancer Treatments: Optimizing the Role of Patient-Reported Data April 25, 2017 Hyatt Regency Bethesda 1 Bethesda Metro Center Bethesda, MD 20814 CO-SPONSORED BY: Critical Path Institute U.S. Food and Drug Administration Workshop Agenda 7:30-8:15 am Registration and Continental Breakfast – Regency I and II 8:15-8:30 am Welcome and Opening Remarks Paul G.......
May 9, 2017 - May 10, 2017
Advancing CDISC Standards for Biosensors Assessments in Clinical Drug Trials: 2017 Biometric Monitoring Device WorkshopMay 9-10, 2017 Bethesda North Marriott Hotel and Conference Center Bethesda, MD Meeting Overview/Objectives: Review contemporary use cases for mobile biosensor assessments of three domains of function that are impacted by Neurological Disorders (mobility/sleep/cognitive performance). Review & address key regulatory considerations for various Contexts-of-Use. Convene CDISC Standard experts to advance a plan that enables data......
April 26, 2017 - April 27, 2017
Eighth Annual Patient-Reported Outcome Consortium WorkshopApril 26 – 27, 2017 Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814 On April 26-27, 2017 the EIGHTH ANNUAL PATIENT-REPORTED OUTCOME CONSORTIUM WORKSHOP was held in Bethesda, Maryland. The overall Workshop objectives were to: • Provide an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program; • Describe progress within the PRO......